Issue 2 of Volume 13 of GaBI Journal starts with a Review Article by Paul et al., titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries’. The review focuses on treatment of non-communicable diseases as these disproportionately affect people living in low- and middle-income countries compared to high-income countries. Challenges identified include weaker regulatory frameworks, dependence on importation, low awareness of biosimilars, and the need for effective policies encouraging access to and use of biosimilars. The review identifies additional criteria, beyond price, that may help stakeholders in low- and middle-income countries select quality-assured biosimilars.
The issue continues with a Perspective from Michael S Reilly and Ralph D McKibbin on misinformation about interchangeable biosimilars which they claim undermines US health policy, physician confidence, and patient health. The views of these authors have been aired before and readers will have to decide on whether they find them convincing.
This is followed by a short Special Report authored by Professor Irene Krämer and Dr Judith Thiesen on ‘Extended stability data on small molecule anticancer medicinal products – anything new? Any additional information necessary?’. The authors highlight that small molecules remain an essential part of combination chemotherapy, but note that although many studies on the extended stability of small molecule preparations have been published, not all licensed medicinal products and stability-determining factors are covered in these. Different dosages and concentrations, new types of containers, formulation changes of the starting material, and advanced administration technologies continuously require additional in-use stability studies.
The remainder of the issue comprises 21 short reports describing physicochemical stability determinations of numerous small molecule anticancer medicinal products, all by Professor Irene Krämer, Dr Frank Erdnuess and Dr Judith Thiesen. These investigate various reconstitution diluents and different containers. The products included in the study are Doxorubicin Accord, Epirubicin Accord, Idarubicin Accord, Mitoxantrone Accord, Bortezomib Accord, Irinotecan Accord, Topotecan Accord, Etoposide Accord, Vinorelbine Accord, Carboplatin Accord, Cisplatin Accord, Oxaliplatin Accord, Azacitidine Accord, Cytarabine Accord, Fluorouracil Accord, Gemcitabine Accord, Cabazitaxel Accord, Docetaxel Accord, Methotrexate Accord, Pemetrexed Accord and Fludarabine Accord. These reports identify appropriate storage times for the diluted products in defined containers and storage temperatures.
Robin Thorpe, PhD., FRCPath
Editor-in-Chief, GaBIJournal
Disclosure of Conflict of Interest Statement is available upon request.
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